Evaluation of the Validity of Preemptive Therapy against Cytomegalovirus Disease Based on Antigenemia Assay with a Cutoff of 20 Positive Cells per Two Slides

Kana Sakamoto, Hideki Nakasone, Hidenori Wada, Ryoko Yamasaki, Yuko Ishihara, Koji Kawamura, Masahiro Ashizawa, Miki Sato, Kiriko Terasako-Saito, Tomohito Machishima, Shun Ichi Kimura, Misato Kikuchi, Shinichi Kako, Junya Kanda, Rie Yamazaki, Aki Tanihara, Junji Nishida, Yoshinobu Kanda

Research output: Contribution to journalArticle

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Abstract

Background:Preemptive therapy with ganciclovir (GCV) based on the results of a cytomegalovirus (CMV) antigenemia assay is a standard strategy for preventing CMV disease after allogeneic hematopoietic cell transplantation (HCT). However, the appropriate threshold of antigenemia-positive cells for deciding when to start GCV remains unclear.Patients:This retrospective study included 80 recipients who received HCT from an alternative donor between 2007 and 2011. In 2009, we switched the threshold from 3 (3A group, n=24) to 20 (20A group, n=56) antigenemia-positive cells per two slides for preemptive therapy after HCT from an alternative donor.Results:Early CMV disease within 100 days after HCT was observed in one patient in the 20A group. Antiviral agents including GCV, val-GCV, and foscarnet were given in 17 (71%) and 36 (64%) patients in the 3A and 20A groups, respectively (p=0.23). In 13 (23%) patients in the 20A group, the initiation of preemptive therapy was avoided because of the change in the cutoff value for CMV antigenemia. However, the total dose of GCV was not different between the two groups. The use of steroid was significantly associated with CMV antigenemia of at least 20 positive cells among patients with low-level antigenemia at the first detection.Conclusion:The increased threshold up to 20 positive cells for starting preemptive therapy was not associated with a significant increase in CMV disease, but the total dose of GCV was not reduced and there was one early CMV disease in the 20A group. We should explore how to identify patients who are at high risk for increased antigenemia among patients with low-level antigenemia, but at least, preemptive therapy should not be withheld in patients who are already receiving systemic steroid.

Original languageEnglish
Article numbere73754
JournalPLoS One
Volume8
Issue number9
DOIs
Publication statusPublished - 2013 Sep 5
Externally publishedYes

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Cytomegalovirus
Ganciclovir
Assays
Cells
therapeutics
cell transplantation
Cell Transplantation
assays
cells
Therapeutics
Steroids
Foscarnet
steroids
Tissue Donors
antiviral agents
Antiviral Agents
dosage
retrospective studies
Retrospective Studies

ASJC Scopus subject areas

  • Medicine(all)
  • Biochemistry, Genetics and Molecular Biology(all)
  • Agricultural and Biological Sciences(all)

Cite this

Evaluation of the Validity of Preemptive Therapy against Cytomegalovirus Disease Based on Antigenemia Assay with a Cutoff of 20 Positive Cells per Two Slides. / Sakamoto, Kana; Nakasone, Hideki; Wada, Hidenori; Yamasaki, Ryoko; Ishihara, Yuko; Kawamura, Koji; Ashizawa, Masahiro; Sato, Miki; Terasako-Saito, Kiriko; Machishima, Tomohito; Kimura, Shun Ichi; Kikuchi, Misato; Kako, Shinichi; Kanda, Junya; Yamazaki, Rie; Tanihara, Aki; Nishida, Junji; Kanda, Yoshinobu.

In: PLoS One, Vol. 8, No. 9, e73754, 05.09.2013.

Research output: Contribution to journalArticle

Sakamoto, K, Nakasone, H, Wada, H, Yamasaki, R, Ishihara, Y, Kawamura, K, Ashizawa, M, Sato, M, Terasako-Saito, K, Machishima, T, Kimura, SI, Kikuchi, M, Kako, S, Kanda, J, Yamazaki, R, Tanihara, A, Nishida, J & Kanda, Y 2013, 'Evaluation of the Validity of Preemptive Therapy against Cytomegalovirus Disease Based on Antigenemia Assay with a Cutoff of 20 Positive Cells per Two Slides', PLoS One, vol. 8, no. 9, e73754. https://doi.org/10.1371/journal.pone.0073754
Sakamoto, Kana ; Nakasone, Hideki ; Wada, Hidenori ; Yamasaki, Ryoko ; Ishihara, Yuko ; Kawamura, Koji ; Ashizawa, Masahiro ; Sato, Miki ; Terasako-Saito, Kiriko ; Machishima, Tomohito ; Kimura, Shun Ichi ; Kikuchi, Misato ; Kako, Shinichi ; Kanda, Junya ; Yamazaki, Rie ; Tanihara, Aki ; Nishida, Junji ; Kanda, Yoshinobu. / Evaluation of the Validity of Preemptive Therapy against Cytomegalovirus Disease Based on Antigenemia Assay with a Cutoff of 20 Positive Cells per Two Slides. In: PLoS One. 2013 ; Vol. 8, No. 9.
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abstract = "Background:Preemptive therapy with ganciclovir (GCV) based on the results of a cytomegalovirus (CMV) antigenemia assay is a standard strategy for preventing CMV disease after allogeneic hematopoietic cell transplantation (HCT). However, the appropriate threshold of antigenemia-positive cells for deciding when to start GCV remains unclear.Patients:This retrospective study included 80 recipients who received HCT from an alternative donor between 2007 and 2011. In 2009, we switched the threshold from 3 (3A group, n=24) to 20 (20A group, n=56) antigenemia-positive cells per two slides for preemptive therapy after HCT from an alternative donor.Results:Early CMV disease within 100 days after HCT was observed in one patient in the 20A group. Antiviral agents including GCV, val-GCV, and foscarnet were given in 17 (71{\%}) and 36 (64{\%}) patients in the 3A and 20A groups, respectively (p=0.23). In 13 (23{\%}) patients in the 20A group, the initiation of preemptive therapy was avoided because of the change in the cutoff value for CMV antigenemia. However, the total dose of GCV was not different between the two groups. The use of steroid was significantly associated with CMV antigenemia of at least 20 positive cells among patients with low-level antigenemia at the first detection.Conclusion:The increased threshold up to 20 positive cells for starting preemptive therapy was not associated with a significant increase in CMV disease, but the total dose of GCV was not reduced and there was one early CMV disease in the 20A group. We should explore how to identify patients who are at high risk for increased antigenemia among patients with low-level antigenemia, but at least, preemptive therapy should not be withheld in patients who are already receiving systemic steroid.",
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AU - Wada, Hidenori

AU - Yamasaki, Ryoko

AU - Ishihara, Yuko

AU - Kawamura, Koji

AU - Ashizawa, Masahiro

AU - Sato, Miki

AU - Terasako-Saito, Kiriko

AU - Machishima, Tomohito

AU - Kimura, Shun Ichi

AU - Kikuchi, Misato

AU - Kako, Shinichi

AU - Kanda, Junya

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AU - Nishida, Junji

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N2 - Background:Preemptive therapy with ganciclovir (GCV) based on the results of a cytomegalovirus (CMV) antigenemia assay is a standard strategy for preventing CMV disease after allogeneic hematopoietic cell transplantation (HCT). However, the appropriate threshold of antigenemia-positive cells for deciding when to start GCV remains unclear.Patients:This retrospective study included 80 recipients who received HCT from an alternative donor between 2007 and 2011. In 2009, we switched the threshold from 3 (3A group, n=24) to 20 (20A group, n=56) antigenemia-positive cells per two slides for preemptive therapy after HCT from an alternative donor.Results:Early CMV disease within 100 days after HCT was observed in one patient in the 20A group. Antiviral agents including GCV, val-GCV, and foscarnet were given in 17 (71%) and 36 (64%) patients in the 3A and 20A groups, respectively (p=0.23). In 13 (23%) patients in the 20A group, the initiation of preemptive therapy was avoided because of the change in the cutoff value for CMV antigenemia. However, the total dose of GCV was not different between the two groups. The use of steroid was significantly associated with CMV antigenemia of at least 20 positive cells among patients with low-level antigenemia at the first detection.Conclusion:The increased threshold up to 20 positive cells for starting preemptive therapy was not associated with a significant increase in CMV disease, but the total dose of GCV was not reduced and there was one early CMV disease in the 20A group. We should explore how to identify patients who are at high risk for increased antigenemia among patients with low-level antigenemia, but at least, preemptive therapy should not be withheld in patients who are already receiving systemic steroid.

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